Y-6 Sublingual Tablets for Patients With Acute Ischemic Stroke

• Y-6 (Drug): each tablet of Y-6 contained 6 mg of dexborneol and 25 mg of cilostazol; Both groups took one tablet q12h for 28 days.
• Y-6 placebo (Drug): each tablet of Y-6 placebo contained 0.06 mg of dexborneol and 0 mg of cilostazol. Both groups took one tablet q12h for 28 days.

Primary outcomes

• Proportion of subjects whose mRS recover to 0-1 at 90 days after randomization. [90 days]: mRS recover to 0-1

Secondary outcomes

• •mRS at 90 days after randomization [90 days]: mRS (0-6); the scale ranges from 0 to 5, where 0 indicates no symptoms, and 5 signifies severe disability requiring continuous care and assistance. 6, denotes death.
• • Changes in NIHSS from baseline to 1 day, 7 days and 28 days after randomization； [from baseline to 1 day, 7 days and 28 days]: Changes in NIHSS; the total score ranges from 0 to 42, with lower scores indicating better neurological status.
• • Proportion of patients with early neurological deterioration at 1 day after randomization; [at 1 day]: early neurological deterioration
• • Proportion of subjects with combined vascular events at 90 days after randomization. [90 days]: combined vascular events

Other outcomes

• • Incidence and severity of treatment emergent adverse events (TEAEs) across treatment groups [During the 90 days]: TEAEs
• • Changes in laboratory test results after treatment; [During the 90 days]: Changes in laboratory test results (such as the red blood cell count, white blood cell count, platelets, blood biochemical indicators, etc.. )
• • Changes in vital signs after treatment [During the 90 days]: • Changes in vital signs after treatment（ including blood pressure, pulse, breathing, and other indicators.）
• • Changes in physical examination findings after treatment [During the 90 days]: • Changes in physical examination findings after treatment: Lungs, Gastrointestinal tract, Urinary system, Musculoskeletal system, Skin, Lymph nodes, et
• • Incidence of symptomatic intracranial haemorrhage at 28 days after treatment (per Heidelberg heamorrhage classification) [at 28 days]: Symptomatic intracranial haemorrhage Heidelberg heamorrhage classification
• • Incidence of any bleeding events after treatment [During the 90 days]: • Incidence of any bleeding events after treatment
• • Incidence of vascular deaths； [During the 90 days]: • Incidence of vascular deaths；
• • Incidence of all-cause deaths after treatment [During the 90 days]: • Incidence of all-cause deaths after treatment
• • Incidence of platelet count ≤100×10^9/L after treatment [During the 90 days]: • Incidence of platelet count ≤100×10\^9/L after treatment

Sex: All, ages: 35 Years to 80 Years

Inclusion Criteria:

* 35 years old ≤ Age ≤ 80 years old;
* Patients with acute ischemic stroke diagnosed within 24 hours of onset (time from onset to start of endovascular treatment);
* Patients with first stroke or mRS score 0-1 prior to this onset ;
* Patients with acute intracranial large vessel occlusion (LVO) confirmed by imaging examination, including occlusion of intracranial segments of internal carotid arteries, T-shaped bifurcation, MCA M1 and/or M2 segments and ACA A1 and/or A2 segments;
* ASPECTS score ≥ 6 at screening;
* 6<NIHSS score ≤ 25 after this onset;
* Patients who had the indications for endovascular treatment and were scheduled for endovascular treatment;
* Patients or his/her legal representatives were able to understand and sign the informed consent.

Exclusion Criteria:

* Patients who are allergic to the active ingredients or excipients of investigational products；
* Severe disorder of consciousness at screening: NIHSS 1a consciousness level ≥2 points;
* Patients with previously diagnosed intracranial haemorrhage at screening, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/external hematoma, etc.;
* Patients with previously diagnosed intracranial tumor, arteriovenous malformation, or aneurysm at screening;
* Patients with previously diagnosed congestive heart failure at screening;
* Patients with bilateral LVO at anterior circulation or LVO at posterior circulation or LVO of unknown aetiology at screening;
* Patients who have received treatment with warfarin, novel oral anticoagulants, argatroban, snake venom, defibrase, lumbrokinase and batroxobin after onset;
* Patients with severe hematologic abnormality or severe hepatic insufficiency or renal insufficiency and received dialysis for various reasons at screening (hematologic abnormality was defined as platelet count <100×109/L; severe hepatic insufficiency was defined as ALT > 3 × ULN or AST >3 × ULN; severe renal insufficiency was defined as serum creatinine >3.0 mg/dl (265.2 μmol/L) or creatinine clearance < 30 ml/min);
* Patients with previously diagnosed hemorrhagic tendency (including but not limited to): hemorrhagic retinopathy or hereditary hemorrhagic disorders, such as hemophilia, at screening;
* Patients with refractory hypertension that is difficult to be controlled by medication (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg);
* Patients with history of major head trauma or stroke within 1 month prior to randomization;
* Patients who have received intracranial or spinal surgery within 3 months prior to randomization;
* Patients with history of major surgery or serious physical trauma within 1 month prior to randomization;
* Male subjects (or their mates) or female subjects who had planned to have a child during the whole study period and within 3 months after the end of the study period or were unwilling to use one or more non-drug contraceptive methods (e.g., complete abstinence, condoms, ligation, etc.) during the study period;
* Patients with contraindications to known contrast agents or other contrast agents;
* Patients who plan to receive other surgical or intervention therapy within 3 months, which might require discontinuation of the study drugs;
* Patients with life expectancy of less than 3 months;
* Patients who have received treatment of investigational drugs or devices within previous 3 months;
* Other investigator-evaluated conditions which may influence the compliance of patients or where it is not suitable for patients to participate in this trial.